Opdivo/Yervoy Drug Combo Toxic For Most Cancer Patients: Study

New research suggests that side effects of Opdivo and Yervoy drug combinations may raise toxicity to dangerous levels among cancer patients, placing them at risk of severe injury. 

Researchers with the Memorial Sloan Kettering Cancer Center and Well Cornell Medical College in New York published a study this month in the medical journal JAMA Oncology, warning that as many as nine out of 10 patients given the drug combo suffered significant immune-related adverse events.

Opdivo (nivolumab) and Yervoy (ipilimumab) are members of a class of cancer drugs known as Immune checkpoint inhibitors (ICIs). Both are manufactured and sold by Bristol-Myers Squibb, for treatment of melanoma skin cancer, and they are often combined together for treatment.

The study involved a cohort of 64 adults with advanced or unresectable melanoma, who were placed on a treatment involving multiple doses of Opdivo and Yervoy. The drugs were administered every three weeks, for up to four doses, between December 2014 and January 2016.

According to the findings, only 39% of the patients were able to tolerate all four doses. The researchers noted that most who discontinued treatment stopped due to toxicity side effects. The study found that 91% of the patients had clinically significant immune-related adverse events, and 72% of the patients needed systemic steroid treatment.

In addition, half of the patients had an emergency room visit, 11% developed hyperglycemia, and more than a third required hospital admission due to immune-related adverse events. The study also found that four patients who stopped the combination therapy early developed new immune system adverse events more than 16 weeks after treatments had ended.

“We observed a 91% incidence of clinically significant immune-related AEs leading to frequent emergency department visits, hospitalizations, and systemic immunosuppression,” the researchers warned. “Immuno-oncology trials should routinely report these metrics. Most patients do not tolerate 4 doses of (Opdivo and Yervoy); however, 4 doses may not be required for clinical benefit.”

In November 2016, a similar study was published in the New England Journal of Medicine, which found that a combination of Opdivo and Yervoy may increase the risk of a life-threatening heart condition. In that study, researchers warned that two patients died after developing myositis with rhabdomyolysis, as well as electrical instability in the heart. They also found T-cell and macrophage infiltrates in the hearts of the patients.

A 2016 study by Johns Hopkins researchers also linked Opdivo and Yervoy to immune-related adverse events, which could manifest as inflammatory arthritis and sicca syndrome.

Other types of immune responses have been linked to the drugs, which strengthens the chances that the drugs can cause arthritis as well. During the original clinical trials for Yervoy and Opdivo, increased risks were detected for inflammatory bowel diseases, lung inflammation, and other side effects that are considered immune-related.

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